Microfluidic-based Tactile Sensor in Cardiac Rehabilitation

NCT04812600 | Unknown

• 1 other identifier: 19-04-FB-0100
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.

Conditions

Cardiovascular Diseases; Vascular Stiffness; Endothelial Dysfunction

Keywords

Exercise; vascular disease; cardiac rehabilitation

Outcome Measures

Primary Outcomes (4)

• Micro-tactile sensor assessment of arterial stiffness change to exercise

  Elasticity (unit measure: pascal) of arterial wall will be assessed.

  The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

• Micro-tactile sensor assessment of arterial viscosity change to exercise

  Damping (unit measure: pascal x sec) of the arterial wall will be assessed.

  The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

• Micro-tactile sensor assessment of arterial radius change to exercise

  Size of the artery lumen (unit measure: mm) will be assessed.

  The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

• Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise

  Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.

  The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

Study Arms (1)

Cardiac Rehabilitation

Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of exercise.

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are undergoing Phase II (outpatient) cardiac rehabilitation at Sentara Heart Hospital (Norfolk, Va) and meet the inclusion and exclusion criteria listed will be recruited for the study.

You may qualify if:

• Age 45-70
• Subjects who qualify for cardiac rehabilitation via doctor's orders

You may not qualify if:

• ●Physical limitations which would preclude one from performing exercise.

Sponsors & Collaborators

• Zhili hao: lead
• Eastern Virginia Medical School: collaborator

Study Sites (1)

Sentara Heart Hospital

Norfolk, Virginia, 23501, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Vascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julie Hao, Ph.D.

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Hao, Ph.D.

CONTACT

757-683-6734; zlhao@odu.edu

Leryn Reynolds

CONTACT

757-683-4974; lreynold@odu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 23, 2021
• Study Start: March 20, 2021
• Primary Completion: March 20, 2022
• Study Completion: March 20, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)